Study on the harmonization of weight(filling)variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation
GENG Ying
DING Rui
WEI Ning-yi
ZHANG Qi-ming
XU Xin-yi
SHANG Yue
LIAO Ping
YANG Quan
LIU Jia-nan
MA Ling
CHEN Hua
Abstract：Weight(filling)variation is an important critical quality attribute for pharmaceutical preparations,and is one of the critical aspects for the uniformity of dosage unit testing.In the ICH tripartite pharmacopoeias(USP,EP and JP),the harmonized general chapter on uniformity of dosage units(ICH Q4B Annex 6),utilizing a unified attribute and variable sampling plan.In General Requirements for Preparations of Chinese Pharmacopoeia,the Weight(Filling)Variation test has always used an attribute sampling plan,and there are differences with the Weight(Filling)Variation test in the ICH general chapter on uniformity of dosage units in terms of the preparation scope,sampling plan,and acceptance criteria.After the harmonization process with ICH Q4B,the newly added general chapter<0940 Uniformity of Dosage Units>was incorporated in Chinese Pharmacopoeia 2025 edition.In this paper,the harmonization consideration including the preparation scope,sampling plan and acceptance criteria was reviewed and interpreted in detail for Weight(Filling)Variation test described both in<General Requirements for Preparations>and in<0940 Uniformity of Dosage Units>.The harmonization with ICH can further improve China's drug regulatory capacity and facilitate drug quality control to align with international standards.
Keywords：Chinese Pharmacopoeiaweight(filling)variation testICHinternational harmonizationuniformity of unit dosestatisticsdata simulation
Publication Date：2026-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 903-910 )